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This is a phase 2 crossover, randomized, placebo-controlled, single-blind, repeat dose study in PBH subjects to determine the effect of mizagliflozin on adverse events and postprandial glucose excursions.
This is a phase 2 crossover, randomized, placebo-controlled, single-blind, repeat dose study in PBH subjects to determine the effect of mizagliflozin on adverse events and postprandial glucose excursions. This study will examine repeat doses of mizagliflozin and placebo while also evaluating dosing regimen. Up to 15 subjects are expected to complete the study. Subjects will be randomly assigned to a treatment arm within a cohort. Each subject should receive placebo and 2 active dose regimens in a crossover fashion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Subjects will receive placebo and two doses of encapsulated mizagliflozin over three dosing periods. Once and twice daily dosing will be examined. |
|
| Cohort 2 | Experimental | Subjects will receive placebo and two doses of encapsulated mizagliflozin over three dosing periods. Twice and three times daily dosing will be examined. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mizagliflozin | Drug | Encapsulated |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of participants with adverse events | Through study completion, 43 days |
| Vital Signs | Number of participants with abnormal vital signs | Through study completion, 43 days |
| Laboratory Tests | Number of participants with abnormal laboratory tests | Through study completion, 43 days |
| Glucose nadir after dosing | Time course of glucose concentrations during MMTT | 0-3 hours following liquid meal |
| Measure | Description | Time Frame |
|---|---|---|
| MMTT peak glucose concentration after dosing | Time course of glucose concentrations during MMTT | 0-3 hours following liquid meal |
| MMTT peak insulin concentration after dosing | Time course of insulin concentrations during MMTT |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford | Palo Alto | California | 94304 | United States | ||
| University of Colorado / Anschutz Medical Campus |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 21, 2026 | May 12, 2026 | 8 | ||
| Jun 9, 2026 |
| ID | Term |
|---|---|
| C000624546 | mizagliflozin |
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| Drug |
Encapsulated |
|
| 0-3 hours following liquid meal |
| MMTT time to peak glucose concentration after dosing | Time course of glucose concentrations during MMTT | 0-3 hours following liquid meal |
| MMTT time to peak insulin concentration after dosing | Time course of insulin concentrations during MMTT | 0-3 hours following liquid meal |
| MMTT glucose concentration | MMTT glucose area under the curve (AUC0-1, AUC0-2, and AUC0-3) after dosing | 0-3 hours following liquid meal |
| MMTT insulin concentration | MMTT insulin area under the curve (AUC0-1, AUC0-2, and AUC0-3) after dosing | 0-3 hours following liquid meal |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Jul 6, 2026 |
| 9 |